It has been reported in the literature that the reduction of elevated plasma cholesterol will decrease the risk of myocardial infarction secondary to atherosclerotic coronary heart disease in humans. It has been documented that plasma cholesterol levels decline to low levels in patients who are maintained on a total parenteral nutrition (TPN) program for extended periods of time. In such a program, all of the nutritional requirements are provided by the intravenous infusion of a solution containing a desired combination of amino acids, essential vitamins, minerals and trace elements, as well as dextrose for non protein caloric requirements.
Infusion of a modified fat free TPN amino acid formulation, Atheromine.TM., has been reported to induce a significant reduction in plasma cholesterol levels accompanied by regression of atherosclerosis in both animals and humans. "Regression of Atherosclerosis by the Intravenous Infusion of Specific Biochemical Nutrient Substrates in Animals and Humans", Dudrick, S. J., Annals of Surgery, Vol. 206, No. 3, pages 296-315 (1987), the disclosure of which is incorporated herein by reference. Atheromine.TM. amino acid formulation is disclosed in U.S. patent application Ser. No. 287,620, filed Dec. 16, 1988 for Method and Substrate Composition for Treating Atherosclerosis, the disclosure of which is herein incorporated by reference. In that study correlations between plasma amino acids and plasma cholesterol levels were demonstrated using a totally intravenous fat free diet containing 18 L-amino acids formulated in quantities and ratios deemed optimal for reducing plasma cholesterol levels in each patient. A number of amino acids, namely arginine, phenylalanine, isoleucine, valine, serine, aspartic acid and leucine were found to have a very strong inverse correlation between plasma amino acids and plasma cholesterol levels. However, in that study the reduction in plasma cholesterol levels and regression of atherosclerosis were limited to the direct intravenous infusion of the Atheromine.TM. amino acid solution. Oral administration of the amino acid composition was found to be ineffective in animals and humans in reducing plasma cholesterol or inducing regression of atherosclerosis.